Medical Device Registration in
Uganda
Ministry of Health
Regulatory Authority
Medical Device Regulation
- Ministerial decree ADM.140/323/01 of 20th July 2020
Official Language
English, Swahili
Classification
Class A, B, C, D
Registration Process
- Determine the medical device classification
- Appoint your Authorised Representative in Uganda
- Registration can be via:
Track 1 – for products approved in IMDRF countries
Track 2 – for products prequalified by WHO
Track 3 – for products with no prior approval
- The registration will be done via NDAMIS portal
- Once approved, the device can be marketed in Uganda
Documents Required
- Accurately detail application letter (Hard and soft copy)
- Bank deposit slip (prove of payment)
- Sample of the product (if applicable)
- Documentation/Dossier
- Prior market history and approvals
Post-market Requirements
Authorized Representative
Yes
License Validity
5 years